BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 18480143 · Received January 9, 2024

    Report

    Report Number
    2955842-2024-10135
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 14, 2023
    Report Date
    December 15, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE VESSEL SEALER EXTEND INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT COULD NOT BE TESTED IN-HOUSE. THE INSTRUMENT WAS RETURNED WITH THE POWER CORD CUT OFF. THE PART CANNOT BE TESTED DUE TO THIS DAMAGE.

    Additional Manufacturer Narrative · 0

    A RETURN MATERIAL AUTHORIZATION (RMA) WAS ISSUED TO EVALUATE THE VESSEL SEALER EXTEND INSTRUMENT. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HIATAL HERNIA SURGICAL PROCEDURE, THE CUSTOMER REPORTED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS CLAMPED ON THE AORTA AND WOULD NOT RELEASE WITH CONSOLE CONTROLS OR MANUAL CONTROLS. INTUITIVE SURGICAL, INC. (ISI) TECHNICAL SUPPORT ENGINEER (TSE) WAS CALLED FOR AN EMERGENCY RELEASE. PER RELATED PATIENT IDENTIFIER (B)(6), THE CUSTOMER REPORTED THE SURGEON WAS UNABLE TO CONTROL THE VESSEL SEALER INSTRUMENT. TSE VIEWED SYSTEM LOGS AND NOTICED THE INSTRUMENT INSTALLED ON ARM 3 BUT THE SURGEON HAD CONTROL OF ARM 4. SURGEON PRESSED THE ARM SWAP PEDAL BUT STATED THAT HE HAD NO CONTROL OF THE INSTRUMENT THAT WAS GRASPING THE AORTA. THE TSE RECOMMENDED TO PUT THE SYSTEM INTO A FAULT STATED IN ORDER TO OPEN THE JAWS AND REMOVE THE SUSPECT INSTRUMENT IF THE SURGEON WAS ABLE TO DO SO UNDER THE CURRENT CIRCUMSTANCES. SURGEON STATED THAT HE WAS ABLE TO PROCEED WITH RECOMMENDATIONS AND PLACED THE SYSTEM INTO A FAULT STATE BY PRESSING THE E-STOP BUTTON. STAFF WAS ABLE TO SUCCESSFULLY REMOVE THE SUSPECT INSTRUMENT, RECOVER THE FAULT, INSTALL A SPARE VSE INSTRUMENT SUCCESSFULLY AND THE SURGEON PROCEEDED WITH THE CASE. THE TSE RECOMMENDED TO RETURN THE SUSPECT INSTRUMENT FOR INVESTIGATION. CUSTOMER AGREED. COMPLAINT HAS BEEN DOCUMENTED AND REPORT WAS CLOSED. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. ISI FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE HAPPENED WHILE THE SURGEON¿S HEAD INSIDE THE SURGEON CONSOLE¿S HIGH RESOLUTION STEREO VIEWER. IT IS UNKNOWN IF THE ISSUE OCCURRED WHILE THE SURGEON WAS ATTEMPTING TO MANIPULATE INSTRUMENTS FROM THE SURGEON CONSOLE. THEY WERE UNABLE TO MOVE THE JAWS. UNKNOWN IF THE MOVEMENTS OF THE SURGEON SCALE APPROPRIATELY TO THE INSTRUMENT. UNKNOWN IF THE INSTRUMENT MOVED IN THE INTENDED DIRECTION. NO INSTRUMENT-TO-INSTRUMENT OR SYSTEM ARM-TO-ARM INTERFERENCE. NO EXTERNAL COLLISIONS. ONCE THE ISSUE WAS OBSERVED THEY FOUND ANOTHER INSTRUMENT. UNKNOWN WHAT ACTION WAS BEING TAKEN AND/OR INTENDED WHEN THE ISSUE OCCURRED. THE DRAPE WAS NOT AVAILABLE FOR RETURN. NO INJURY TO THE PATIENT AS A RESULT OF THE EVENT. THE DEVICE WAS INSPECTED PRIOR TO USE AND NOTHING OUT OF THE ORDINARY WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605521 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 K11230922 0922 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DA VINCI INSTRUMENTS AND ACCESSORIES